Pilot Test of Patient Decision Aid for Opioid Use Disorder

Opioid Use Disorder Clinical Trial

— PtDA-MAT  

Official title:

Pilot Test of Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394261
• Other study ID #: OPIOD1
• Status: Completed
• Phase: N/A
• Start date: June 14, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.

Description:

In response to RFA-DA-18-005 (Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants, R21/R33), this project will develop and test a patient decision support tool called Patient Decision Aid for Medication-Assisted Treatment (PtDA-MAT) for use in the CA H&SS. The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with OUD along a continuum of care. The project will conduct 1 year of R21 to develop and pilot-test the PtDA-MAT to facilitate shared decision making in CA H&SS, followed by 3 years of R33 to assess the effectiveness of the PtDA-MAT in a randomized controlled trial.

The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)

Exclusion Criteria:

• Significant or unstable medical or psychiatric illness that may interfere with study participation

Related Conditions & MeSH terms

• Disease
• Opioid Use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Patient Decision Aid
PtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options.

Locations

Country	Name	City	State
United States	Tarzana Treatment Centers, Inc.	Tarzana	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Retention	Treatment retention will be defined as number of days from initial treatment admission to either MAT discontinuation or most recent clinic visit followed by 2 months gap in treatment	3 months
Secondary	Drug screening results	Primarily opioid-negative urine testing (as collected by clinics as part of routine care) and other substance use per self-report (e.g., cannabis, benzodiazepines, cocaine, amphetamines)	3 month
Secondary	Treatment Adherence	Treatment Adherence defined as proportion of clinic visits attended	3 month